Post on 28-Aug-2018
Volume 2 Issue No.2 January to March 2018 F o o d a n d D r u g A d m i n i s t r a t i o n
“ We will work together
more than you’ve ever seen before.
This is our TIME.
Intention + Investment + Effort
Will all equate to RESULTS.”
NELA CHARADE G. PUNO, RPh
FDA Director-General
FDA Newsletter
1. LICENSING OF ESTABLISHMENTS
2. REGISTRATION OF HEALTH PRODUCTS
3. POST-MARKET SURVEILLANCE
4. ENFORCEMENT
EDITOR’s NOTE
This is the FDA Newsletter for the 1st Quarter of
2018.
Our deepest thanks to all our contributors.
Editorial Board Ms. Nela Charade G. Puno, RPh
Atty. Ronald R. De Veyra Ms. Cecilia C. Matienzo
Editor-in-Chief
Dr. Oscar Gutierrez, Jr.
Editorial Staff
Ms. Merlita Pedron Mr. Rudolph Tan
Mr. Joseph Albert Espinar Ms. Lyn Balmes
Ms. Rhea Paunan Ms. Aiko Barcelon
Ms. Gabrielle Gabriel Ms. Adora Mabilangan
Ms. Vanessa Olivar Ms. Eda-Ann Abiad
Ms. Katherine Pamela Imperial Mr. Ray Mark Morante
Ms. Rhea Paunan
CONTRIBUTORS
Atty. MICHELLE LAPUZ Legal Support Services Center
Atty. KATHERINE M. AUSTRIA-LOCK
Center for Drug Regulation and Research
ENGR. ANA TRINIDAD RIVERA
Center for Cosmetic Regulation and Research
MS. PILAR MARILYN PAGAYUNAN
Center for Food Regulation and Research
ENGR. BAYANI SAN JUAN
Center for Devices Radiation Regulation and Health Research
Ms. RACQUEL ALVENDIA
Administration and Finance Office
Ms. CECILIA MATIENZO
Policy And Planning Service
MS. JOCELYN E. BALDERRAMA
Common Services Laboratory
Gen. ALLEN BANTOLO (ret)
Regulatory Enforcement Unit
Regional Clusters MS. JESUSA JOYCE N. CIRUNAY
ATTY. EMILIO L. POLIG JR. ATTY. ANABELLE C. DE VEYRA
MS. DEBORAH S. LEGASPI ENGR. ANNETTE B. TAN
The FDA NEWSLETTER is a quarterly publication of the Policy and Planning Service
Policy Dissemination and Training Division
To Safeguard
Public Health and
Consumer Safety
To be an internationally recognized center of excellence in
health product regulation by 2026.
To guarantee the safety, quality, purity, efficacy of
health products in order to protect and promote the
right to health of the general public.
T he 3 Marching Orders, namely Zero
Backlog, 72-hour Response Time, and
Strengthened Enforcement, are the
backbones of the Agency's institutional reforms,
which allow us to focus our efforts towards
administrative efficiency and increased regulatory
coverage for better consumer safety and welfare
protection.
The FDA is steadily moving forward with our 5
-Year Development Plan, and in 2018 we will
continue to build critical systems to support critical
public services.
The TUV Rheinland’s issuance of a new and
upgraded ISO9001:2015 Certificate after their 2nd
surveillance audit with upgrade underscores the
FDA milestones and achievements in 2017. Our
progress from ISO9001:2008 to ISO9001:2015 has
been a challenge, but one that we meet head-on.
We stand together as one FDA. The regulatory
Centers for drugs, food, cosmetics, and devices, the
laboratories, the administrative, legal, and policy
support, and our enforcement arm together make
the Agency strong.
It has only been 19 months since I assumed
the office as FDA Director-General. We have
shown that investment and effort coupled with
good intentions and modest ambition produces
results. We will work together more than you’ve
ever seen before. This is our TIME.
An average Filipino household spends
more than half of every one hundred pesos
earned on FDA-regulated products. It is in the
DNA of the FDA to serve the interest of the
Consumers.
The FDA is committed to greater
transparency. We have launched a new FDA
Website (www.fda.gov.ph) to ensure that
users from the consumer, industry and
government sectors will have access to timely,
useful and relevant information. However, it
is still a work in progress.
The FDA Regulatory Enforcement Unit has
been doing an immense job in protecting the
consumers from fake, unregistered, harmful
and toxic health products that are being
peddled by unscrupulous businessmen and
criminals. The FDA will remain relentless
against violators. I enjoin all well-meaning
entrepreneurs to secure their License to
Operate and product market authorizations.
FROM THE DESK OF THE
M s . N e l a c h a r a d e g . p u n o
FDA Director General
“It is in the DNA of the
FDA to serve the interest of
the Consumers.”
FDA DG Puno as Guest of Honor in ceremonial military
uniform during the PNP Flag Raising Ceremony
F DA Director General, Ms. Nela Charade G. Puno, was accorded Arrival Honors befitting a Guest of Honor
during the Philippine National Police (PNP) Flag Raising Ceremony last February 26. She was welcomed
by PNP DG Bato del Rosario at the PNP Headquarters. DG Puno expressed her profound gratitude to the
PNP for its continuous support to FDA in getting rid of counterfeit, unregistered, and misbranded health products in
the market, through FDA-PNP Joint Task Force D-PUNCH (Destroy Products Unfit for the Consumption of Humans).
T he Regulatory Enforcement Unit (REU) in collaboration with the PNP has so far seized over P75M worth of
unregistered and fake drugs and medicines, cosmetics, medical devices and violative hazardous urban household substances products. It has so far padlocked 53 establishments, initiated 16 criminal cases, with 21 cases still under preliminary investigation. Three search warrants have been served, and 17 entrapment operations have been carried out. Around 35 seizure operations have been conducted.
The relentless pursuit of the REU against erring establishments, unscrupulous businessmen and gross violators of RA 9711 will continue and intensify in 2018. Well-meant establishments are encouraged to secure their License to Operate and Certificates of Product Registration and Notifications to avoid FDA penalties and sanctions.
REU-PNP D-PUNCH
2018 ANNUAL PLAN SNAPSHOT
• Republic Act (RA) 9711, FDA Act of 2009 • RA 3720, Food, Drug and Cosmetic Act of 1963, • RA 5921 (1969), or The Pharmacy Law, • Presidential Decree No. 881 (1972), or The Household
Hazardous Act, • Executive Order No. 51 (1986), or The Milk Code of
the Philippines • RA 6675, or The Generics Act Of 1988, • RA 7394(1991), or The Consumer Act of the Philip-
pines, • RA 7581 (1992 ) or The Price Act, and • RA 8172 (1995), or The ASIN Law, • RA 8203 (1996), or The Special Law on Counterfeit
Drug, and • RA 8976 (2000), or The Food Fortification Law
• RA 10611, or The Food Safety Act of 2013 • PD 856, or The Code of Sanitation of the Philippines • RA 9502, or The Universally Accessible Cheaper and
Quality Medicine Act of 2008, • RA 9257, or The Expanded Senior Citizens Act of 2003 • RA 10354, or The Responsible Parenthood and Repro-
ductive Health Bill of 2012 • RA 9165, or The Comprehensive Dangerous Drugs Act
of 2002 • RA 10623 (2013), or The Price Act • RA 9211, or The Tobacco Regulation Act of 2003 • RA 10643 or the Graphic Health Warnings Law • PD 1372, Amendment to PD No. 480 Which Created
The Radiation Health Office
The FDA is migrating to a new FDA Website. Once
completed, it will be more accessible, functional, faster and
friendly to users.
The following are some of the major national laws (so far) that are currently implemented and enforced by the
FDA, with other government agencies:
T he FDA passed the TUV Rheinland 2nd follow
-up audit surveillance. Its accreditation was
upgraded to ISO9001:2015 last February 12
to 14. The FDA’s Scope of Accreditation was
expanded to include Post-Market Surveillance, in
addition to Licensing of Health Product Establishments
and Registration of Health Products.
Under the strong leadership of DG Nela Charade G.
Puno, the FDA passed the audit without any
nonconformity findings. However, there were minor
observations that needs to be addressed for
improvement.
The FDA audit site included the FDA offices in
Alabang and 17 FDA Regional Offices, and 2 Satellite
Laboratories.
The FDA Quality Management System (QMS) was
verified by means of random sampling. Verifications
were made on the FDA’s workflow—compliance to the
sets of standard requirements and documentation of
the management system, taking into account the
special features of the organization’s business activities
and the applicable statutory and regulatory
requirements. Extensive interviews were conducted.
Upon the recommendation of the auditors, TUV
Rheinland awarded the ISO9001:2015 Certificate of
Accreditation.
The next surveillance audit will be in February 2019.
FDA UPGRADED
TO ISO9001:2015
STANDARD
L ast March 15, the FDA Management Team, led by
the Director-General Nela Charade G. Puno,
reviewed the FDA’s performance during the 1st Quarter of
the year. The different offices and centers presented their
accomplishments based on their targets. Issues and
concerns were also discussed during the meeting.
As part of the monitoring and evaluation, DG Puno
reminded all participants to work on the 3 Marching Orders
and the 6 Imperative Strategies. She requested all Centers
to continuously improve their efficiency in issuing License
to Operate (LTO) and Certificate of Product Registration
(CPR)/Notification based on Anti-Red Tape Act - Citizen’s
Charter Commitment (ARTA-CCC) of the FDA.
She enjoined the Center Directors to continue its
collaboration with the Regulatory Enforcement Unit (REU)
in safeguarding public health and consumer safety.
The OIC of the Office of the Deputy Director General (DDG)
for Field Regulation Operations Office, Atty. Emilio Polig, Jr.,
gave the Opening Remarks, while the DDG– for Internal
Management, Atty. Ronald R. De Veyra, delivered the
Closing Message.
Licensing of Establishments
6,646 License to Operate (LTO) were issued;
92.75% (6,164 ) LTOs were processed within
the ARTA-CCC.
Product Registration
21,130 CPR/Notification were issued; 75.18%
(15,887) were issued within the ARTA-CC C.
Certificates and Certification
(Batch Certification, Lot Release Certificate, Export
Certificate, Certificate of Free Sale, among others)
74.90% of the Certificates were issued within
ARTA-CCC.
Laboratory Analysis
94.02% (16,21) samples of the products
tested passed the analysis for safety, potency
or quality; only 5.97% (103) were found to be
out of the specifications.
Post-Market Surveillance and Routine Inspection
Health Products. Out of the 3,510 health products that were subjected to PMS, 75% (2,633) were found compliant with the FDA pre-approved specifications.
Establishments. Out of the 7,079 establishments inspected, 89.77% (6,355) were found to have remained compliant with FDA requirements as Manufacturer, Distributor (importer, exporter, wholesaler), Traders or Drug Outlet.
DG Nela Charade Puno with the Participants
Submission of complete and correct licensing and
registration requirements during initial application
almost always ensure issuance of license and product
certification within ARTA-CCS
FDA Budget: PRIMACY OF PUBLIC HEALTH AND CONSUMER PROTECTION
• The current administration increased the 2017 budget by 52.69% over the past administration in 2016 In 2016 and 2017, the government allotted to FDA the budget of P698,521,344.44 and P1,325,635,993.06, respectively, which translates to P6.98/consumer in 2016 and P13.25/consumer in 2017.
• The FDA revenue from the Industry Sector in 2016 and 2017 was P409,307,261.93 and P394,737,104.69, respectively. These figures represents the cost recovered by the FDA for legitimizing business operators and their products .The 2017 collection was P14,570,157.24 less than in 2016. In effect, the government subsidized the amount of P289,214,082.51 in 2016 and P930,898,888.36 in 2017. Reliance on legislated budget is not enough, given the thrust of the current Administration and the FDA 5-Year Development Plan to increase consumer safety and welfare protection, on top of supporting the “ease of doing business” and investment in the country,
• The existing schedule of fees is based on the 2001 guidelines. Seventeen years ago, the Philippine population was only 79.67M. The peso-dollar exchange rate was P38. The number of FDA employees was only around 300, which has now tripled. The FDA was an agency operating only in Alabang, but it now includes 5 Regional Clusters composed of 18 regions , 81 provinces and 2 satellite laboratories. The licensing and registration systems were manually processed. The FDA Centers are currently enhancing or migrating to online licensing and registration system, and the ideal ratio of computer to employees is now 1:1. The Philippine economy was not as robust then as it is today. The number of establishments and health products being regulated has increased logarithmically to more than 302,452, and is still increasing. The number of national laws (Republic Acts, Presidential Decrees or Executive Orders) that need to be implemented stood at only 11 in 2001, but has now more than doubled. The agency needs to cope with demands of further liberalization of trade through regional and inter-regional free trade agreements. Today, social media has firmly established its influence on consumers behavior and decisions. Consumers are now more demanding than ever.
R epublic Act No. 9711 (FDA Act of 2009) was signed into law in recognition of the FDA’s vital role in ensuring public health and consumer
safety. It authorized the FDA to retain its income to attain financial stability. The provisions of RA 9711, however, have yet to be fully realized before FDA can attain financial independence.
The current FDA administration gave high priority to
consumer protection. Proactive programs for public health and consumer
protection have costs. The activities cannot be delayed, suspended, compromised or interrupted due to budgetary constraints, or even due to external influences.
The business and industry sectors are ultimately
responsible and accountable for the performance of their products and brands in the market. They are called upon to cooperate and collaborate with the FDA in ensuring public health and consumer safety.
It must be emphasized that the role of the FDA does not
end in the issuance of licenses to regulated establishments and pre-market approval of health products to the business sector. FDA must assure the consumers that the licensed establishments maintain the safety, efficacy and quality of their
product as pre-approved by the FDA. The FDA must ensure that establishments and health products, especially in the food and medical device sectors, that are not yet under the regulatory folds comply with the FDA licensing and registration requirements. Product and brand owners should adhere to the standards of fair trade practices. Product labels and health claims, as well as advertisement and promotional materials, should not be misleading and deceive the consumers.
All these, among others, are covered by the Post-Market
Surveillance (PMS) and Enforcement. Failure to comply with FDA-approved product specifications may result to product recall to protect the consumers. PMS, more than anything else, is applicable to FDA-registered products. For unregistered and contraband products, the FDA’s response is strict Enforcement - the D-PUNCH (Destroy Products Unfit for the Consumption of Human.
Health products that enter through the national borders
must be pre-approved by the FDA before they are shipped or exported to the Philippines.
All unregistered, harmful, toxic, hazardous, spurious,
falsified, falsely labelled, and counterfeit health products are seized, confiscated and destroyed by the FDA.
.
CONSUMERS MATTER
CONSUMERS MATTER
The FDA is accountable to the health and well-being of all Filipino consumers, around 106 million and still growing. This number includes highly susceptible sectors of the population like infants, children, pregnant mothers, senior citizens, and those who are ill.
The consumers spent on health products reached Php 1.4 T for pharmaceutical and healthcare
products and Php 5.8 T in food and drinks (2011). *
* other products regulated by the FDA
include household hazardous substances, like toys, childcare articles, urban pesticides, and medical devices, like diagnostic kits, equipment and instruments, among others
New Schedule of Fees on June 2018
T he FDA issued FDA Advisory No. 2018-117 announcing that it will be implementing a new schedule of fees for licensing and
registration, among other FDA services, effective 30 June 2018. Further to this, the FDA announced that will no longer accept cash payments starting on the same date. All payments to FDA shall be done through the following:
Bancnet Online Payment www.bancnetonline.com
Landbank of the Philippines (LBP) Oncoll
Payment
The specific details on the Collection Policy and Procedure are found in FDA Circular 2017-010, which can be accessed at the FDA website. Interested parties may call the FDAC at (02) 821-1176 / (02) 821-1177 for more information. You may also e-mail us at info@fda.gov.ph.
The new schedule of fees is based on the provision of RA 9711 and existing DBM guidelines.
Legal Basis
S ection 54, Chapter 12, Book IV of Executive
Order No. 292 (Administrative Code of 1987)
authorizes the Heads of Bureaus, Offices and
Agencies, upon approval of the Secretary, to charge
and collect fees to recover the cost of services
rendered.
The Office of the President issued Administrative
Order No. 31, s. 2012, which authorizes all heads of
departments, bureaus, commissions, agencies,
offices and instrumentalities of the national
government, including government-owned and
controlled corporations to rationalize the rates of
their fees and charges and increase the existing rates
and impose new fees and charges. AO No. 31, s.
2012, repealed Memo Circular No. 137, s. 2007,
which required clearance from the NEDA Board
before imposing new fees or increases in existing
fees.
In spite of a clear legal basis, the FDA consulted
the stakeholders, the industry and business sectors,
over the last 9 years to come up with a final
guidelines. Six BFAD Directors and FDA OIC or
Acting DG, including the current full-pledged DG
conducted public consultations at different levels of
the organization.
As mandated by RA 9711, the FDA funds will be
used for public health and consumer safety and
welfare protection, and to assure fair trade practices,
among others.
FDA Action Center (FDAC) The creation of the FDAC is pursuant
to FDA Order No. 2017-010.
H uman Resource Development is about helping employees
develop their personal and professional organizational skills, knowledge, and abilities In line
with the HRD Program, the HRDD invites resource speakers per month to address the FDA employees and management during the Flag Raising Ceremony. The activity is meant to uplift and inspire the FDA employees in their work and in their personal lives. Public service is performed by employees called civil servants. Government agencies are not profit-oriented organizations. The employees are motivated differently. The services that they render require high level of education, training and experiences. Civil servants are different breed with strong public ethos—to give something to the public and community through their works. INTEGRITY. On February 05, 2018, Mr. Mario P. Contemprato talked about “Integrity”. Mr. M. P. Contemprato is a graduate of 3 courses, namely Bachelor of Theology, AB History and Bachelor of Laws. He is the Associate Pastor and Outreach Department Head of Church of God in Dasmarinas, Cavite. TRANSPARENCY. On March 05, 2018, Mr. Rodelio C. dela Cruz, Ordained Minister and Associate Pastor
of the Church of God in Dasmarinas, Cavite, discussed the importance of “Transparency”. He is the Chairman of the Board and School Director, Kerusso Christian Academy. He is a Licensed Civil Engineer with MBA degree. He used to be a
Manager of the Metropolitan Waterworks and Sewerage System and Maynilad Water Services, Inc.
HRD Matters
Pastor Mario P. Contemprato and DDG-IM Atty. Ronald R. De Veyra
Pastor Rodelio C. dela Cruz with FDA DG Nela Charade G. Puno
Shaping the Servant-Hero CSC
The staff of HRDD with Mr. Rodelio C. dela Cruz (6th from left) with his wife (8th from left)
Wom
en’s M
onth
FDA INTERNSHIP PROGRAM
2018 1st Batch of Interns with Mr. Joseph Albert A. Espinar (front row, right most), Policy and Planning Service
No. of Interns School Course
1 Technical University of the Philippines Chemical Engineering
3 De La Salle Health Sciences Institute BS Biochemistry
1 Adamson University BS Information Technology
11 Pamantasan ng Lungsod ng Muntinlupa BSBA Human Resource Management
2 Pamantasan ng Lungsod ng Muntinlupa BS Psychology
1 AMA Computer College BS Information Technology
2 Pamantasan ng Lungsod ng Muntinlupa BS Psychology
3 Polytechnic University of the Philippines BS Information Technology
9 Pamantasan ng Lungsod ng Muntinlupa BS Information Technology
8 Pamantasan ng Lungsod ng Muntinlupa BS Information Technology
7 Eulogio "Amang" Rodriguez Institute of Science and Technology BS Applied Physics
3 University of the Philippines BS Applied Physics
2 Pamantasan ng Lungsod ng Muntinlupa BS Information Technology
6 Pamantasan ng Lungsod ng Muntinlupa BS Information Technology
2 Central Luzon University BSBA Marketing Management
5 Pamantasan ng Lungsod ng Muntinlupa BSBA Human Resource Management
2 Pamantasan ng Lungsod ng Muntinlupa BS Information Technology
T he FDA is accepting interns for the whole year.
Around 68 interns were accepted this quarter and
were deployed in key FDA Centers and Offices, in
various divisions and sections.
At the end of their program, the interns will be
evaluated.
Interns will also be asked to provide feedback on
the FDA intern program for continuous improvement.
Some FDA interns in the past have already gained
employment at the FDA.
O n February 28, 2018, students from the
Institute of Clinical Laboratory Sciences
Siliman University, a private research
university in Dumaguete, Negros Oriental,
visited the FDA in Alabang for a field trip.
The FDA Director-General, Ms. Nela Charade Puno
personally welcomed the Dean, the B.S. Medical
Technology students, and the faculty. DG Puno engaged
the students for more than an hour of discussions,
motivating them to continue to follow their dreams and
passions in life.
The students were divided into 3 batches for the
quick guided tour of the Central Service Laboratory.
They proceeded to the Research Institute for Tropical
Medicine in the afternoon.
The field trip was coordinated by the Policy
Dissemination and Training Division, Policy and Planning
Service with the Common Services Laboratory.
DG Engages Students from Silliman University
O n March 26, 2018, right after the General Assembly, the
FDA Coop elected four new Members of the Board of
Directors, namely Ms. Lanette Lee Querubin, Ms. Maria Essa
Tuason, Ms. Grace Medina, and Ms. Thelma Perez.
The FDA Coop is chaired by Ms. Emelita Delmiguez. The rest of the
Members of the BOD who has so far served for a ear are Ms.
Marivic Paulino, Mr. Daniel Joren, Mr. Timothy Moises Mendoza,
and Dr. Oscar G. Gutierrez, Jr
GEN
ERA
L ASSEM
BLY
Ms. Merlita Pedron explains the issues on loan interests.
Mr. Herminio Dela Cruz
from the Office of the Mayor of Muntinlupa City
Mindanao West Cluster Receives CSC-ARTA Excellent Rating
T he FDA Mindanao West Cluster in Zamboanga
City passed the Civil Service Commission (CSC)
Anti-Red Tape Act-Report Card Survey (ARTA-
RCS) with a rating of 90.73%, which is
equivalent to Excellent. The survey was held on
September 26 to 29, 2018.
The FDA Mindanao West Cluster (MWC) puts them
a step away from receiving the coveted CSC Seal of
Excellence Award. It needs to pass the two-phase
validation process to finally qualify for the Seal of
Excellence Award.
Republic Act 9485, otherwise known as the Anti-Red
Tape Act (ARTA) of 2007, aims to improve efficiency in
the delivery of government service by reducing red tape
and preventing graft and corruption. All government
offices are mandated to take appropriate measures to
promote transparency with regard to the manner
transacting with the public.
CCRR Engages the Dermatologist in a Dialogue
O n Feb 23, 2018 the Chief of the CCRR Licensing
and Regulation Division, Ms. Maria Theresa M.
Gutierrez, and the OIC of the CCRR Product Research
and Standards Division, Ms. Melody M. Zamudio,
oriented the participants from the Dermatologists of the
Asian Hospitals on the licensing and product notification
requirements of the Food and Drug Administration. The
professional group of dermatologists organized the
seminar to increase compliance of their members to
FDA regulatory requirements. The role of the
manufacture, trading, distribution and retailing of
cosmetic products in quality and safety assurance were
discussed.
Consumers, including the patients, have the right to
be informed about the status of cosmetic products used
on them.
The CCRR welcomes invitations from the cosmetic
industry sectors and professional organizations to
increase awareness and advocacy on the importance of
securing FDA authorizations, with the end view of
ensuring the safety and quality of health products made
available to consumers, especially the naïve and
unsuspecting consumers.
The orientation was held at the Café Breton located
in Westgate, Alabang, Muntinlupa City.
CCRR Completes e-Learning Course
T he Center for Cosmetics Regulation and Research (CCRR), upon the invitation of the Development Academy of the Philippines
(DAP) in cooperation with Asian Productivity Organization (APO), participated in the E-Learning Course on Management Innovation in SMEs on 15-18 January 2018 at the DAP Conference Center, San Miguel Ave., Pasig City. The E-Learning course aims to: (1) enhance participants’ understanding of the concept and basic principles of management innovation in SMEs for
higher productivity, (2) increase capacity of SMEs to achieve long-term sustainability through the use of appropriate models of management innovations, and (3) share knowledge in implementation strategies for successful application of management innovation in SMEs. The cyber-learning opportunity was conducted by Dr. Nomita Sharma and Mr. Hideyuki Ezaki through interactive lectures (video conference), group discussion, and field visit. An assessment test was conducted simultaneously with participants from Cambodia, Japan, Malaysia, Mongolia, Sri Lanka and Thailand. Other government agencies, namely DTI, SUCs, TESDA, PSA, DOST, Muslim Affairs Commission, and the private sector were also represented.
CCRR Subject Matter Expert
M s. Ofelyn Cabrido, Food and Drug Regulation Officer IV of the Product Research and Development Division,
Center for Cosmetic Regulation and Research (CCRR) was invited by the Cosmetic Toiletries Fragrances Association of the Philippines (CTFAP) to act as subject matter expert or resource person to their seminar/workshop on Product Information File (PIF). PIF is one of the important Post-Market Surveillance requirements of the CCRR. It is one of the ASEAN Cosmetic Directives agreed requirement to ensure protection of consumers against harmful cosmetics. Ms. Cabrido discussed the provisions of
FDA Circular 2018-001 on Reiteration on the Requirement for (PIF) Product Information File. The workshop was conducted at the Palms Country Club, Filinevst, Alabang, Muntilupa City.
Unregistered Goree Whitening Cream Ms. Ofelyn Cabrido was also interviewed by TV Channel 7, GMA 24 Oras News field reporter on March 26, 2018 in connection with the unregistered Goree Skin Whitening Cream that caused serious skin burn of the armpit of a woman. The product was tested and was found to contain more than 2,000 ppm mercury (Hg), way beyond the standard of 1 ppm. The FDA issued an advisory to warn the public and consumers. The FDA inspectors were ordered to seize and confiscate the said product.
U pon the invitation of DTI Bureau of Domestic Trade
Promotion, the Policy and Planning Service (PPS)
coordinated the participation of the Center for Food
Regulation and Research (CFRR) and the FDA Academy in
the 2018 Sikat Pinoy National Food Fair. The 5-day event
was held at the Megatrade Halls 1-3, SM Megamall,
Mandaluyong City from March 14 to 18. A booth was assigned to the FDA which were manned
by the FDA representatives from CFRR and the PPS. It was an excellent opportunity for the FDA to reach
out to the MSMEs who have not yet secured their FDA
licenses and product registrations. The FDA
authorizations are also important in ensuring
competitiveness of locally produced products, and
possibly to gain access to the international market or be
part of the global value chain.
Sikat Pinoy National Food Fair 2018
https://azraelsmerryland.blogspot.com/2018/03/sikat-pinoy-national-food-fair-2018.html